Goldenberg 1996.
Study characteristics | ||
Methods | Design: cross‐over Duration: 6 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: ≥ 30 on 0‐100 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 31 Age in years (mean, SD): 43.2 (9.1) Gender: 28/31 were female Pain duration/fibromyalgia symptoms in months (mean, SD): 72.6 (48.1) |
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Interventions | Placebo
Amitriptyline 25 mg + placebo
Fluoxetine 20 mg + placebo
Amitriptyline 25 mg + fluoxetine 20 mg
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Outcomes | Pain intensity Quality of life Sleep Mood Withdrawal |
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Missing data methods | Completer analysis only | |
Funding source | Non‐pharmaceutical: Lot Page Fund, Newton‐Wellesley Hospital, Newton | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a table of random numbers |
Allocation concealment (selection bias) | Low risk | Randomisation and allocation was performed in the hospital pharmacy |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical tablets and double‐dummy to match dosing schedules across groups |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer‐only analysis, unequal attrition across arms and high overall dropout Attrition Total: 12/31 (38.7%) Placebo: 1/31 (3.2%) Amitriptyline 25 mg: 1/31 (3.2%) Fluoxetine 20 mg: 4/31 (12.9%) Amitriptyline 25 mg + fluoxetine 20 mg: 5/31 (16.1%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified |